Table 1– Baseline subject and disease characteristics: intention-to-treat population
PlaceboTralokinumab
Combined tralokinumab150 mg300 mg600 mg
Subjects n48146475148
Age yrs47.2±9.847.4±11.143.4±11.148.7±11.049.8±10.4
Male15 (31.3)63 (43.2)28 (59.6)15 (29.4)20 (41.7)
White42 (87.5)136 (93.2)46 (97.9)46 (90.2)44 (91.7)
BMI kg·m−227.0 (18.9–34.8)27.1 (18.5–35.3)26.6 (18.9–35.3)27.5 (18.5–34.9)27.2 (19.2–34.6)
FEV1 L1.94±0.48+2.01±0.652.20±0.671.90±0.591.96±0.66
FEV1 % pred61.4±12.3+61.2±12.361.9±12.761.1±12.660.5±11.8
FEV1 reversibility %#27.0±17.930.2±16.728.3±17.733.4±18.329.3±14.4
FVC L3.25±0.80+3.26±1.023.56±0.953.08±1.013.15±1.04
PEF L284.9±79.6+313.2±112.3341.2±118.6290.5±97.0309.9±117.5
Median ICS dose μg·day−110001000100010001000
Subjects receiving daily OCS0 (0)9 (6.2)3 (6.4)3 (5.9)3 (6.3)
Rescue β2-agonist use puffs·day−12.60±1.68+2.47±1.852.80±2.032.04±1.512.60±1.95
ACQ-6 score2.60±0.54+2.68±0.632.68±0.622.63±0.502.72±0.75
Overall AQLQ(S) score4.15±0.83§4.07±0.87ƒ3.90±0.88##4.15±0.80##4.16±0.94§
  • Data are presented as mean±sd, n (%) or mean (range), unless otherwise stated. BMI: body mass index; FEV1: forced expiratory volume in 1 s; % pred: % predicted; FVC: forced vital capacity; PEF: peak expiratory flow; ICS: inhaled corticosteroids; OCS: oral corticosteroids; ACQ-6: Asthma Control Questionnaire, mean of six individual item scores; AQLQ(S): Asthma Quality of Life Questionnaire with standardised activities. #: mean reversibility of subjects who demonstrated reversibility during screening (excluding those who reported historical reversibility); : beclometasone equivalent; +: n=47; §: n=36; ƒ: n=114; ##: n=39.